FDA says its plan to improve the post-marketing drug safety system embraces most of the recommendations made by the Institute of Medicine in a 2006 report. But in several respects, the agency's response isn't exactly what IoM had in mind.
At a press conference held to announce the Food & Drug Administration’s response to the Institute of Medicine’s report on drug safety, the agency’s top brass stressed that FDA is following the committee’s recommendations in its ongoing plan to improve the post-marketing drug safety system.
At first glance, it certainly looks that way: in response to the 25 recommendations from the IoM committee’s September 2006...
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The Pink Sheet explores how regulatory approvals for Leqembi differ around the world, and looks at what is coming next.
Experts from EUCOPE explain why the Council of the EU’s position on the proposed overhaul of the general pharmaceutical legislation could offer more predictability for companies than the commission’s initial offering.
